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COVID-19, consultations and clinical trials: 6 questions for Dominique Duchêne

Dominique Duchêne, Project Manager, Clinical Research Associate (CRA) Manager at I-Motion, the paediatric clinical trial platform.

If I could ask you who you are and what your mission is, and how long you have been working at the Institute?
I joined the Institute of Myology in 2011 and I am currently Project Manager at I-Motion. This platform, based at the Trousseau Hospital (Paris, 12th arrondissement), was created in 2015, at the behest of four partners, the Institute of Myology, AFM-Téléthon, the AP-HP (Paris public hospital system), and the AIM, which is our management representative. I-Motion is a paediatric clinical trial platform dedicated to neuromuscular diseases, whose purpose is to respond to the emergence of innovative therapies for diseases that have long been considered incurable.

The I-Motion platform has been headed by Prof. Odile Boespflug-Tanguy since July 2019. As investigators, we conduct industrial therapeutic trials and we also develop disease natural history trials as sponsor.

Our doctors also provide a specialised consultation in the field of neuromuscular diseases at the hospital.
I am in charge of setting up of new studies, budgets and the supervision of the various trials conducted at I-Motion. I manage a team of eight Clinical Research Associates (CRAs).

How has your daily life been since the beginning of the epidemic? What organisational measures have you put in place?
We have 17 trials that are currently ongoing (14 therapeutic trials and 3 natural history trials), which represents a total of approximately 100 patients enrolled in clinical trial protocols. This ranges from babies only a few months old to young adults.

The onset of the epidemic forced us to partially close the hospital facilities. Our priority has been the safety of our young patients who are frail in terms of having cardiac and/or respiratory problems. Many of them live far away or come from abroad (mainly Eastern Europe) and it was impossible for them to travel, given their situation and the new health rules restricting movement. Therefore, we had to adapt and quickly find new ways of following up patients remotely, with a view to sending the study treatments and performing examinations (blood tests, ECGs, etc.), which are necessary for the safety of the children we see.

Our four doctors stayed in continuous contact with the patients by telephone or email.

After on-site consultations were stopped in mid-March, we put in place a tele-consultation service and specific protocols to identify emergency cases and to ensure patients were properly followed up.

What difficulties, if any, have you encountered?
When the department had to close its doors and we found ourselves confined, we put in place new follow-up organisational measures with very detailed summary tables so that all the staff (doctors, nurses, secretaries and CRAs) could access all the patient remote follow-up information and we exchanged numerous emails. Clinical research operates with one primary and essential rule: everything must be traced. This generated a very significant exchange of emails between us, but also with the CROs (Contract Research Organisations) and the sponsors.

Indeed, protocol exemptions allowing medicines to be sent and patients to be followed up remotely required authorisation from competent authorities, as well as from ethics committees and sponsors.

The doctors, nurses and CRAs traced all the stages, procedures, follow-up visits, test results, etc. by email.

We were able to send orally-administered treatments to the various patients, even those based abroad. The sponsors ensured the follow-up of patients (in particular, laboratory tests and ECGs) using a dedicated company staffed by nurses.

Things were more complicated for children who needed to receive a weekly intravenous treatment. Young patients based in France were able to receive their injection from our nursing team, who travelled around the whole of France each week. However, for young patients based abroad, the treatment had to be stopped temporarily, because it was no longer possible to travel and we could not find referral doctors in their country able to fulfil these duties.

What is the impact of this situation on you and your colleagues?

This situation has generated a phenomenal amount of extra work for our teams, notably our CRAs, who are the ones really in charge of our trials. They ensure the whole process is cohesive, coordinate the various departments, the assessments, the scheduling, meetings; they help the doctors to contact the families, and with the help of our assistant, they implement the logistics for the travel and accommodation of the children and those accompanying them. They make sure there are no protocol deviations. They trace the entire journey of a patient in ongoing trials and enter all the clinical trial data into an electronic case report form. The data are monitored (checked) by the CROs, appointed by the sponsor.

Since 11 May, we have organised the gradual return of patients to the site.

Since returning to the site, the workload has remained very heavy, since it has been necessary to print all the emails, file them, and update patient files with the follow-up of adverse events occurring and concomitant treatments taken during the confinement period.

Indeed, with the sponsors, we are continuing to search for solutions to achieve the rapid return of our young patients from abroad.

A detailed review of the I-Motion budget was undertaken, study by study and visit by visit, to assess the impact of COVID-19 on our resources.

What positive aspects would you like to share with us?
I would like to stress how much the team is invested and engaged in their mission. All the staff at I-Motion were able to respond to this crisis, adapt quickly and show themselves to be responsive and innovative. This unprecedented situation also revealed a very rich humanity; there was a strengthened solidarity between the staff, but also towards patients and their families, in the process of continuously supporting them, remaining close to them and reassuring them.

Communication was, without a doubt, the key word in this very unusual context.

On a personal level, the confinement left me a bit isolated and I missed normal human contact, as most of us did, but I felt even more invested in researching and finding solutions to allow us to continue our work under the best conditions possible, even while working remotely.

Is there a message you would like to convey?
Once again, I would really like to thank my entire team for the energy demonstrated and the work accomplished over these difficult months. Everyone bent over backwards and significantly exceeded their normal working hours to ensure the well-being of our patients, which remains our main priority. We managed to conduct things in the best way possible, abiding by the rules that had been set, despite the difficulties encountered. For this, I congratulate them!

The families also adapted themselves very successfully to new working hours and new practices. They were grateful to us and their gratitude was a welcome reward for our involvement.

A spirit of initiative, solidarity and resourcefulness emerged for the benefit of the community, and it is also important to stress this.

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